Over the Counter Hearing Aids
The FDA’s Final Rule on Over the Counter (OTC) Hearing Aids took effect this on Monday, October 17, 2022. This guidance is intended to assist licensees in understanding the impact of the Final Rule on Nevada laws and regulations in order to ensure the safety and welfare of the public and align practice with regulatory requirements.
FINAL RULE HIGHLIGHTS
- OTC hearing aids do not require the involvement of a licensed person. As such, this Board’s laws and regulations do not apply to them.
- Non-OTC hearing aids are now defined as prescription devices, but there is no change to the qualifications of who may provide these. Prescription sales are still subject to 21 CFR 801.109.
- A medical evaluation or signed waiver to obtain either category of hearing aids is no longer required by federal law, as 21 CFR 801.421 was repealed. However, the federal rule authorizes states to maintain existing state laws or regulations that require a medical evaluation or signed waiver.
IMPLICATIONS FOR PRACTICE
All existing Nevada laws and regulations in NRS Chapter 637B and NAC Chapter 637B remain in effect in relation to prescription hearing aids, except as indicated below where federal law takes precedence over state law:
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Section
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Section Title
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Summary
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Status After Final Rule
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Impact on Practice
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Sale of hearing aids by catalog, mail or Internet: Conditions; records; regulations.
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Requires a licensee to obtain a medical evaluation or waiver when selling hearing aids by catalog, mail, or Internet.
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REMAINS
IN EFFECT
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Licensees must still obtain a medical evaluation or waiver
ONLY WHEN selling hearing aids by catalog, mail, or Internet.
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Grounds for Initiating Disciplinary Action
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Includes a violation of 21 CFR 801.421 as grounds for disciplinary action.
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NO LONGER APPLICABLE
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21 CFR 801.421 no longer exists, so a violation of the rule
could not be considered grounds for disciplinary action.
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Requirements concerning waiver by client of medical evaluation.
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Describes requirements for obtaining a waiver of medical evaluation.
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CONDITIONALLY
APPLICABLE
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NO LONGER APPLICABLE - REPEALED BY REGULATION CHANGE IN LCB FILE R108-23 EFFECTIVE JUNE 20, 2024 |
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Preparation and retention of health care records and other records.
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Requires waiver of medical evaluation to be included in patient records.
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OTHER RESOURCES
- The Board’s laws and regulations, including this guidance are available on the Board website.
- Additionally, the Board has adopted and posted guidance on OTC hearing aids for consumers and the public.
- Many of the Board’s partners, including the American Academy of Audiology (AAA), American Speech-Language-Hearing Association (ASHA), and the International Hearing Society (IHS) have created OTC Hearing Aid resources for practitioners.